Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Tipranavir(TPV)/Low Dose Ritonavir(r)

No text entered.

Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r)

No text entered.

Total

Total of all reporting groups

Baseline Measures

Tipranavir(TPV)/Low Dose Ritonavir(r)

Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r)

Total

Overall Participants Analyzed [Units: Participants]

435

428

863

Age [1] [Units: Years]Mean (Standard Deviation)

42.5 (8.4)

42.9 (8)

42.7 (8.2)

[1]

3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.

Gender [1] [Units: Participants]

Female

84

64

148

Male

351

364

715

[1]

3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups

Description

Tipranavir(TPV)/Low Dose Ritonavir(r)

No text entered.

Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)

No text entered.

Measured Values

Tipranavir(TPV)/Low Dose Ritonavir(r)

Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)

Participants Analyzed [Units: Participants]

435

428

Treatment Response at Week 2 [Units: Percentage of participants]

51

25.9

Statistical Analysis 1 for Treatment Response at Week 2

Groups [1]

All groups

Method [2]

Cochran-Mantel-Haenszel

P Value [3]

0.0001

Risk Difference (RD) [4]

24.9

95% Confidence Interval

18.6 to 31.1

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

No text entered.

[2]

Other relevant method information, such as adjustments or degrees of freedom:

Weighted by the size of enfuvirtide and protease inhibitor strata

[3]

Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance: